Application 215948

Type: ANDA
Sponsor: ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MIRABEGRON	MIRABEGRON	TABLET, EXTENDED RELEASE;ORAL	25MG	No	No
002	MIRABEGRON	MIRABEGRON	TABLET, EXTENDED RELEASE;ORAL	50MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A215948-001	MIRABEGRON	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB		2024-02-12
A215948-002	MIRABEGRON	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB		2024-02-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A215948-001	AB
A215948-002	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215948-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215948-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215948-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215948-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215948-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215948-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215948-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215948-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215948-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215948-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215948-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215948-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215948-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215948-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215948-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215948-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215948-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215948-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215948-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215948-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215948-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215948-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215948-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215948-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215948-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215948-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215948-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215948-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-12	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215948-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-12	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215948-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-12	`6a51e52b5d6a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215948-001	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-12	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215948-002	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-02-12	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215948-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215948-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215948-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215948-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215948-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215948-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215948-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215948-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215948-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215948-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215948-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215948-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215948-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215948-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215948-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215948-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215948-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215948-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215948-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215948-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215948-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215948-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215948-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215948-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215948-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215948-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215948-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215948-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215948-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215948-002	AB	1	`6a51e52b5d6a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215948-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215948-002	AB	1	`a50c72e98297…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MIRABEGRON	MIRABEGRON	REMEDYREPACK INC.	d0054db9-e38a-4786-be2c-996fa5b8f47d	2026-05-22	Warnings, Adverse reactions	Name fallback brand name: MIRABEGRON generic name: MIRABEGRON
Mirabegron	MIRABEGRON	Ascend Laboratories, LLC	1c9022af-4841-4f3f-9737-1c5eef58e86b	2026-05-22	Warnings, Adverse reactions	Name fallback brand name: Mirabegron generic name: MIRABEGRON
Mirabegron	MIRABEGRON	REMEDYREPACK INC.	b71b939e-8cb1-492c-8311-28f75dc4c682	2026-04-27	Warnings, Adverse reactions	Name fallback brand name: Mirabegron generic name: MIRABEGRON
Mirabegron	MIRABEGRON	Amneal Pharmaceuticals NY LLC	e597023d-6dcc-4d9e-8ce0-2d28a5d862f3	2026-03-26	Warnings, Adverse reactions	Name fallback brand name: Mirabegron generic name: MIRABEGRON
MIRABEGRON	MIRABEGRON	Lupin Pharmaceuticals, Inc.	d22d3d12-8466-46db-bc19-d13e87c6115c	2025-12-24	Warnings, Adverse reactions	Name fallback brand name: MIRABEGRON generic name: MIRABEGRON
Mirabegron	MIRABEGRON	Qilu Pharmaceutical Co., Ltd.	98247602-29b9-4621-8eeb-519e40b883b9	2025-10-21	Warnings, Adverse reactions	Name fallback brand name: Mirabegron generic name: MIRABEGRON
Mirabegron	MIRABEGRON	REMEDYREPACK INC.	5f7a1758-8691-4e53-96d6-a01626ee8140	2025-10-02	Warnings, Adverse reactions	Name fallback brand name: Mirabegron generic name: MIRABEGRON
MIRABEGRON	MIRABEGRON	Bryant Ranch Prepack	00826723-d25e-498a-b8d4-d17e5c14dda5	2025-09-26	Warnings, Adverse reactions	Name fallback brand name: MIRABEGRON generic name: MIRABEGRON
MIRABEGRON	MIRABEGRON	Bryant Ranch Prepack	1a7337a4-2901-4e65-b666-7623fadb78f2	2025-09-26	Warnings, Adverse reactions	Name fallback brand name: MIRABEGRON generic name: MIRABEGRON
MIRABEGRON	MIRABEGRON	Bryant Ranch Prepack	2965e083-b678-43b9-8e13-2efddc0daad0	2025-09-26	Warnings, Adverse reactions	Name fallback brand name: MIRABEGRON generic name: MIRABEGRON
MIRABEGRON	MIRABEGRON	Bryant Ranch Prepack	3bd73250-2b31-4b22-983b-15119846e697	2025-09-26	Warnings, Adverse reactions	Name fallback brand name: MIRABEGRON generic name: MIRABEGRON
Mirabegron	MIRABEGRON	Zydus Lifesciences Limited	461b2b94-205a-4860-9cb4-d30267ada9df	2024-10-09	Warnings, Adverse reactions	Name fallback brand name: Mirabegron generic name: MIRABEGRON
Mirabegron	MIRABEGRON	Zydus Pharmaceuticals (USA) Inc.	2e40eb74-3b2a-47f7-bf31-fe27484f9bd2	2024-10-09	Warnings, Adverse reactions	Name fallback brand name: Mirabegron generic name: MIRABEGRON
Myrbetriq	MIRABEGRON	Astellas Pharma US, Inc.	ba9e9e15-e666-4c56-9271-2e24739cfa2d	2024-08-01	Warnings, Adverse reactions	Name fallback generic name: MIRABEGRON

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73413	ORIG	2023-02-08